Michael Baker’s latest piece adds some valuable color to a very simple chain of potential events.

1. It turns out that lots of Americans personally illegally import prescription drugs. (Canadian sources say 10 million Americans have been served; surveys suggest millions more with other sources.) The Food and Drug Administration (FDA) turns a blind eye.
2. As part of a larger Customs and Border Patrol crackdown on small-dollar imports, many of these drug purchases will get nixed.
3. Where will the customers go for their drugs? Many may turn to the compounding pharmacies.

That’s right. Compounding pharmacies will be permitted to make up a dramatic shortfall in the supply of mass-market drugs. Will the FDA continue to turn a blind eye?

Recall that the FDA ostensibly permits compounding pharmacies to fill a very narrow niche: customized versions of approved medication to meet a specific clinical need, or step in when specific FDA-approved drugs experience temporary shortages. But they are not evaluated by the FDA for safety, efficacy, or quality, nor is there a guarantee that the FDA will regularly inspect compound manufacturers’ facilities.

Despite this, compounders have done things like purchase one of those pricey Super Bowl commercials (Sick of the System; rebuttal here) and engage in large-scale sales of GLP-1s. Regrettably, it is easy to anticipate they will step into the self-importation breach.

It makes no sense to permit the simultaneous existence of two conflicting regulatory regimes governing the production and sale of prescription drugs. One is highly regulated, relatively expensive, and largely safe. The other largely unregulated, relatively cheap, and a dice roll regarding its safety. Whatever the original intention, the FDA needs to either shut down the compounding pathway or commit to enforcing its original, niche intent.